Cleanroom Monitoring Systems Keep Pharma Data Secure

Continuous and secure data acquisition and documentation is especially important in the pharmaceutical industry with its unique production and storage requirements, as well as for proprietary research and development. According to FDA CFR21 Part 11, data acquisition and cleanroom monitoring systems must operate in compliance with GAMP/GMP guidelines.

For effective monitoring, measurement data and limit values for parameters such as Temperature, Humidity, Particle count and Pressure all need to be logged and archived in a format safe from manipulation. Additionally, any user intervention relevant to the processes in question must also be recorded to an audit trail. Delphin Technology’s Expert and Message series data loggers, combined with ProfiSignal analysis software, offers pharma companies a complete system performing all facets of cleanroom monitoring systems including data acquisition, monitoring, reporting and user management.

Application Features:

Secure acquisition of all measurement data acquired from cleanrooms and pharmaceutical production and storage environments

Independent data storage within the Delphin device parallel to PC and network storage

Automated Measurement and Alarms:

Testing the long-term stability of pharmaceutical substances is a particular challenge for pharma process and stability engineers. To this end, many pharmaceutical facilities are equipped with Delphin cleanroom monitoring systems. Here, substances are stored in climate chambers and deep freezers where environmental conditions need to be recorded, archived and tracked. Any changes in operational parameters–such as preset temperatures and threshold values–also need to be recorded in a way that is both reliable and secure.

Increasingly, users are turning to integrated systems supporting alarm management. Systems need to handle alarm acknowledgment and disposition while recording the users’ actions to satisfy audit trail requirements. All digital documents and annotations are recorded in secure, uneditable formats.

Typical Areas of Application:

Environmental monitoring in Clean Rooms

CFR21 Part 11-compliant monitoring for pharmacists

Continual monitoring of production facilities in accordance with the FDA

Fully-integrated monitoring solutions for pharmaceutical production

Automated alarm systems

Professional Measurement Devices:

Delphin Technologies data loggers and data acquisition systems solve a variety of measurement and control problems in environmental applications in labs and industrial settings. Delphin systems feature a variety of analog and digital I/O modules that can accept a wide range of signal types including: Voltage; 4-20 mA Current; Thermocouple; RTD; and Resistance. They also offer powerful computation and alarming capabilities enabling them to process measurements and initiate actions on their own. Delphin systems can be used for local data acquisition and logging when connected to a PC; for remote unattended data collection connected the internet; or as stand-alone devices.